Self assessed health status in Poland: EQ 5D findings from the Polish valuation study

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1 ORIGINAL ARTICLE Self assessed health status in Poland: EQ 5D findings from the Polish valuation study Dominik Golicki 1, Maciej Niewada 2, Michał Jakubczyk 1,3, Witold Wrona 1, Tomasz Hermanowski 1 1 Department of Pharmacoeconomics, Medical University of Warsaw, Warszawa, Poland 2 Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warszawa, Poland 3 Institute of Econometrics, Warsaw School of Economics, Warszawa, Poland Key words EQ 5D, EuroQol, general population, health related quality of life, population norms Abstract Introduction There are no population norms currently available in Poland for any generic health related quality of life (HRQoL) questionnaire for adults. Objectives The aim of the study was to evaluate the health status of a representative sample of the general Polish population using the EQ 5D questionnaire. Material and methods Adult subjects who were visiting patients in 8 medical centers in Warsaw, Skierniewice, and Puławy, were inter viewed during the Polish EQ 5D valuation study. Stratified quota sampling was used. The respondents completed the EQ 5D questionnaire and provided information on age, sex, marital status, education, employment, income, housing conditions, medical history, and smoking habits. The inter views were conducted between February and May Results The final sample (n = 317) was representative of the general Polish population with respect to age and sex. Moderate problems in at least 1 dimension of the HRQoL were reported by 57% of the respondents, while extreme problems by 4.7%. Pain or discomfort was reported by 40% of the respondents, anxiety or depression by 38%. Problems with mobility were reported by 16% of the respondents, with usual activities (work, school) by 13%, and with self care by 3%. The mean state of health recorded on the visual analogue scale (VAS) was 81.6 ±14.4 points. The mean VAS value decreased from 87 and 91 points in the youngest age group to 67 and 72 points in the oldest age group, in men and women, respectively. Conclusions Pain and anxiety are commonly reported problems in the Polish population, especially by young women. EQ 5D is a valuable tool for studying health outcomes and differences in health status within the Polish population. Correspondence to: Dominik Golicki, MD, PhD, Zakład Farmakoekonomiki, Warszawski Uniwersytet Medyczny, ul. Pawińskiego 3a, Warszawa, Poland, phone: , fax: , e mail: dominik.golicki@wum.edu.pl Received: April 27, Revision accepted: July 2, Conflict of inter ests: none declared. Pol Arch Med Wewn. 2010; 120 (7-8): Copyright by Medycyna Praktyczna, Kraków 2010 Introduction According to the World Health Organization, Health is not only the absence of disease, but also physical, social and mental well being. 1 This definition refers to a commonly used term the health related quality of life (HRQoL). 2 Improvement of health status and HRQoL as well as reduction of related inequalities in the general population constitute the main target of the National Health Program in Poland for the years 2007 to A successful implementation of health policy requires a reliable evaluation of its outcomes. The EQ 5D questionnaire is a tool for the evaluation of HRQoL. It is used with a considerable success in cross sectional and longitudinal studies of the human health status, as well as to investigate the efficiency of the healthcare system. In various countries, the use of EQ 5D in clinical settings is supported by the national quality of life population norms, and in pharmacoeconomic analyses by the national norms of the social health state preferences. 4 Publication of the Polish EQ 5D standards of health state utility supports the development and use of pharmacoeconomic analyses in Poland. 5,6 Meanwhile, a widespread use of EQ 5D in clinical practice, or in the assessment of health policy outcomes, is limited by the lack of the Polish population norms. The aim of our study was to evaluate how individuals perceive their own health on the basis of the EQ 5D questionnaire, completed in a 276 POLSKIE ARCHIWUM MEDYCYNY WEWNĘTRZNEJ 2010; 120 (7-8)

2 Table 1 Characteristics of the population sample men (by age), % women (by age), % General Polish population a total total Study population (n = 317) mean age ±SD, yrs NA 42.6 ±15.6 education level, % marital status, % work, % low middle high single married/living together widowed divorced employed unemployed pensioner retired student housewife/househusband, % NA 3.8 believes in life after death, % NA 62.5 a source: Central Statistical Office, Poland 2007 data 7 Abbreviations: NA not available, SD standard deviation randomly sampled group of Polish respondents, adjusted for age and sex. Material and methods Study population The study was conducted during the Polish EQ 5D valuation study. 5 In the first half of 2008, 10 trained undergraduate medical students surveyed a representative sample of the Polish adult population. Survey quotas with respect to age and sex were prepared on the basis of demographic data obtained from the Central Statistical Office in Poland. 7 Face to face inter views were conducted with the visitors of inpatients at 8 Polish medical centers: in Warsaw, Skierniewice, and Puławy. Each respondent was asked to reply to the EQ 5D questionnaire, provide sociodemographic data (age, sex, marital status, education, employment, income, housing tenure, medical history, smoking habits) and perform the valuation exercise (results described elsewhere). 5 The study was approved by the Medical University of Warsaw ethics committee (KB/24/2008). All respondents gave written informed consent. EQ 5D The EQ 5D questionnaire consists of 2 parts: EQ 5D descriptive system and EQ visual analogue scale (EQ VAS). 4,8 The EQ 5D descriptive system covers the following 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each of these dimensions has 3 levels: no problems, some problems, and severe problems. A respondent is asked to indicate his or her state of health by ticking the box next to the most appropriate statement for each of the 5 dimensions. A combination of 1 level from each of the 5 dimensions defines the state of health. A total of 243 possible states are thus defined. EQ 5D states of health, defined by the EQ 5D descriptive system, may be converted into a single summary index by applying a formula that attaches weight to each level in each dimension. The value set has been derived for EQ 5D in Poland using the time trade off valuation technique and was used in our study. EQ VAS is a standard, vertical, 20 cm long VAS (similar to a thermometer) for recording an individual s rating of their current HRQoL. The ends of the scale are defined as the best imaginable health state and the worst imaginable health state. 8 Data analysis We analyzed 3 sets of data concerning the quality of life: a subjective evaluation of health by respondents (according to EQ VAS), an objective evaluation of health by respondents (according to the EQ 5D index), and a range of problems within 5 dimensions of HRQoL defined in the EQ 5D descriptive part. We studied the evaluation of HRQoL with respect to the respondents age, sex, and both. Statistical analysis The results were considered statistically significant at the significance level of P <0.05. Two sided confidence inter vals were presented. The normal distribution was verified with the Shapiro Wilk test. The statistical significance of differences between dichotomous variables from 2 independent groups was analyzed with the Fisher s exact test. The differences between inter val variables with nonnormal distribution from 2 independent groups were verified using the Mann Whitney test. The relationship between 2 inter val variables measured in the same group was tested with the Kendall s rank correlation. The statistical analysis was conducted using the StatsDirect software (StatsDirect Ltd, England). Results Study population Between February and May 2008, we conducted 321 inter views. Three respondents did not complete the EQ VAS and 1 person did not complete the descriptive part. In total, 317 questionnaires with a full set of answers were included in the final analysis. ORIGINAL ARTICLE Self assessed health status in Poland

3 100 EQ-VAS score men women P = NS NS NS NS NS age (yrs) Figure 1 Mean self rated health status of respondents (using EQ visual analogue scale [EQ-VAS] scores). Polish population sample by sex and age Abbreviations: NS nonsignificant EQ-index (Polish tariff) The study population comprised 167 women (52.7%). The respondents were aged from 18 to 86 years (mean age, 42.6 ±15.6 years). Detailed characteristics of the study population are presented in TABLE 1. EQ VAS A mean score of the subjective evaluation of HRQoL was 81.6 ±14.4 (95% confidence inter val [CI]: 80.0; 83.1) on a 100 point scale. Individual scores ranged from 10 to 100 points. The mean subjective evaluation of health by men was 81.3 ±13.8 points and was not significantly different from the average score for women (81.8 ±14.9 points). The mean score of health state evaluation according to the VAS was decreasing with age (Kendall s tau b = 0.28; P <0.0001; FIGURE 1). Only in the youngest age group (18 24 years), a statistically significant trend for a higher score in the subjective evaluation of health by women compared with men was observed (90.9 vs. 86.7, respectively; P = ) age (yrs) Figure 2 Mean weighted health status of respondents (the EQ 5D index according to the Polish time trade off tariff) by age groups The EQ 5D index A mean objective evaluation score was 0.91 ±0.11 (95% CI: 0.90; 0.92). Individual scores ranged from 0.28 to The mean objective evaluation of health by men (0.927 ±0.097) was not statistically significantly higher than the average score for women (0.894 ±0.117; P = 0.003). The mean score of health state evaluation according to the EQ 5D index decreased with age (Kendall s tau b = 0.28; P <0.0001; FIGURE 2). In the age groups of years and years, we observed a significantly higher score in the objective health evaluation by men as compared with women, (0.969 vs , P = and vs , P = , respectively). EQ dimensions The incidence of health problems of the study population according to the EQ 5D descriptive system is shown in TABLE 2. Taking into consideration all dimensions, moderate health problems were present in 57.1% of the respondents, while severe health problems in 4.7%. The majority of problems were related to pain/discomfort and anxiety/depression and were more commonly reported by women than by men (P = and P = , respectively; FIGURE 3). Specifically, significant differences between women and men were observed within the pain/discomfort dimension in the age group of years (P = ) and in the anxiety/depression dimension in the age groups of years (P <0.0001) and years (P = , TABLE 3). Discussion Our study showed that both the score of the subjective health evaluation according to the EQ VAS scale and the score of the objective health evaluation according to the descriptive part of the EQ 5D questionnaire decreased with age. The EQ 5D index in the age group of years is significantly higher among men than among women. On average, 2 in 5 women experienced pain/discomfort and anxiety/depression. 278 POLSKIE ARCHIWUM MEDYCYNY WEWNĘTRZNEJ 2010; 120 (7-8)

4 Table 2 Number (percentage) of respondents reporting a problem in each EQ 5D dimension (n = 317) EuroQol dimension Problem moderate extreme any mobility, n (%) 50 (15.8) 2 (0.6) 52 (16.4) self care, n (%) 10 (3.2) 0 (0.0) 10 (3.2) usual activities, n (%) 40 (12.6) 2 (0.6) 42 (13.2) pain/discomfort, n (%) 124 (39.1) 4 (1.3) 128 (40.4) anxiety/depression, n (%) 112 (35.3) 7 (2.2) 119 (37.5) any dimension, n (%) 181 (57.1) 15 (4.7) 187 (59.0) % mobility men women 3 4 self-care usual activities 33 Our study has 2 major limitations. First of all, it was based on a relatively small group of respondents. In other countries, population norms for EQ 5D were formulated on the basis of larger study groups, starting from 464 individuals in Greece and 620 in Japan, 9 to as many as 11,698 respondents in Sweden 10 and 15,700 in Denmark. 11 a 47 pain/ discomfort 27 a 47 anxiety/ depression Figure 3 Self rated health status in Polish population sample (by sex): percentage of respondents reporting any problems using the EQ 5D descriptive system, a P <0.05 This is because the present study aiming to determine population norms for EQ 5D in Poland was only a substudy of the larger Polish EQ 5D valuation study. 5 In the above mentioned project, a sample of 321 respondents gave 7351 individual health state valuations, which was considered sufficient to fulfill the primary study goal. Secondly, our sample of respondents was representative of the Polish population regarding age and sex, but not other variables, such as place of residence or education. In view of the above limitations, our analysis should be perceived as a pilot study. We managed to show a number of correlations, and we confirmed the usefulness of the Polish version of the EQ 5D questionnaire for health state evaluation in the general population. A properly designed study in the future, based on a larger sample that would be representative of the Polish population with regard to more demographic features, should provide a more precise evaluation of the population norms. In the Polish, as well as German, 12 British, 13 and Swedish populations, 10 HRQoL decreases with age and is generally worse among women than among men. The differences concern some detailed quality of life dimensions that deteriorate. In Poland, significant differences were observed within the pain/discomfort and anxiety/depression dimensions. In Sweden, this also concerned the usual activities dimension. 10 In Great Britain, the differences were only observed within the anxiety/depression dimension, 13 and in Germany only within the pain/discomfort and self care dimensions. 12 In Poland, every 3 in 5 respondents reported problems within the EQ 5D dimensions. This rate is higher than in Sweden (54%), Great Britain (43%), or Germany (36%). The problems related to anxiety/depression were reported by 30% more respondents in Table 3 Number (percentage) of respondents reporting problems in each of the EQ 5D dimensions according to age and sex (n = 317) Dimension mobility, n (%) self care, n (%) usual activities, n (%) pain/discomfort, n (%) anxiety/depression, n (%) n = n = n = 57 Age group n = n = n = 28 total 3 (6.5) 1 (1.4) 5 (8.8) 13 (21.0) 11 (20.8) 19 (67.9) men 2 (8.7) 0 (0.0) 1 (3.6) 8 (27.6) 4 (16.7) 9 (81.8) women 1 (4.3) 1 (2.8) 4 (13.8) 5 (15.2) 7 (24.1) 10 (58.8) total 1 (2.2) 0 (0.0) 1 (1.8) 0 (0.0) 2 (3.8) 6 (21.4) men 1 (4.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 2 (18.2) women 0 (0.0) 0 (0.0) 1 (3.4) 0 (0.0) 1 (3.4) 4 (23.5) total 6 (13.0) 2 (2.8) 6 (10.5) 10 (16.1) 4 (7.5) 14 (50.0) men 5 (21.7) 0 (0.0) 1 (3.6) 6 (20.7) 2 (8.3) 5 (45.5) women 1 (4.3) 2 (5.6) 5 (17.2) 4 (12.1) 2 (6.9) 9 (52.9) total 6 (13.0) 22 (31.0) 19 (33.3) 33 (53.2) 28 (52.8) 20 (71.4) men 3 (13.0) 6 (17.1) 6 (21.4) 15 (51.7) 11 (45.8) 9 (81.8) women 3 (13.0) 16 (44.4) 13 (44.8) 18 (54.5) 17 (58.6) 11 (64.7) total 12 (26.1) 27 (38.0) 19 (33.3) 25 (40.3) 23 (43.4) 13 (46.4) men 6 (26.1) 5 (14.3) 4 (14.3) 11 (37.9) 9 (37.5) 6 (54.5) women 6 (26.1) 22 (61.1) 15 (51.7) 14 (42.4) 14 (48.3) 7 (41.2) ORIGINAL ARTICLE Self assessed health status in Poland

5 Poland than in Sweden, nearly 50% more often than in Great Britain, and 10 times more often than in Germany. It has to be noted that the results of our study can be immediately applied to clinical practice in Poland and serve as a reference for individual patients, at a given age and of a given sex. We managed to prove that the Polish version of the EQ 5D questionnaire is highly acceptable and sensitive to some minor changes in the population s state of health. As such, it seems to be an appropriate tool for measuring the outcomes of the adopted health policy. 4 Future studies that will implement the EQ 5D questionnaire to evaluate the health status of the Polish society should be based on larger population samples, representative of the general population with respect to additional demographic features. As far as the health policy is concerned, we recommend to repeat such evaluations regularly, as it is done in Great Britain or the United States. 14 In conclusion, in the Polish population, both subjective and objective perception of the quality of life according to the EQ 5D questionnaire showed that scores decreased with age. Pain and anxiety were reported by every 2 in 5 women. The Polish version of EQ 5D can be a valuable tool for studying health outcomes and inequalities within the Polish population. Warsaw; _wytyczne_HTA_eng_MS.pdf. Accessed March 10, Central Statistical Office [cited 2007 November 15]. gov.pl. Accessed November 15, Cheung K, Oemar M, Oppe M, et al. EQ 5D User Guide. Basic information on how to use EQ 5D: EuroQol Group; Accessed March 10, Szende A, Williams A, eds. Measuring self reported population health: An inter national perspective based on EQ 5D: Springmed Publishing Ltd; Burström K, Johannesson M, Diderichsen F. Swedish population health related quality of life results using the EQ 5D. Qual Life Res. 2001; 10: Sørensen J, Davidsen M, Gudex C, et al. Danish EQ 5D population norms. Scand J Public Health. 2009; 37: König HH, Bernert S, Angermeyer MC, et al.; ESEMeD/MHEDEA 2000 Investigators. Comparison of population health status in six European countries: results of a representative survey using the EQ 5D questionnaire. Med Care. 2009; 47: Kind P, Dolan P, Gudex C, et al. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ. 1998; 316: Fryback DG, Dunham NC, Palta M, et al. US norms for six generic health related quality of life indexes from the National Health Measurement study. Med Care. 2007; 45: Acknowledgements This study was supported by unrestricted grants from GSK Commercial, Pfizer Poland, and Astra Zeneca Pharma Poland. We are grateful to Anna Jabłońska, Anna Jawoszek, Aneta Dwojak, Ola Możeńska, Anna Gąsiewska, Malwina Hołownia, Krzysztof Orłowski, Szymon Zawodnik, Agnieszka Gaczkowska, Adam Golicki, and Łukasz Kołtowski from Student Pharmacoeconomics Chapter, Medical University of Warsaw for assistance in data collection. We are also grateful to Professor Jan J.V. Busschbach from the EuroQol Group for methodo logical support. This study was presented as a poster during the 11th International Society for Pharmacoeconomics and Outcomes Research Annual European Congress, Athens, Greece, November References 1 Bryant D, Schunemann H, Brozek J, et al. Patient reported outcomes: general principles of development and inter pretability. Pol Arch Med Wewn. 2007; 117: Jaeschke R, Guyatt G, Cook D, et al. [Evidence based medicine (EBM), that is medical practice based on current and reliable publications. Part 8: Defining and measuring health related quality of life]. Medycyna Praktyczna. 1999; 4. Polish. 3 Kuszewski K, Goryński P, Wojtyniak B, et al. [National Health Program ]. Attachment to Resolution of the Council of Ministers No 90/2007, May 15, 2007: Ministry of Health 2007; Polish. 4 Brooks R. EuroQol: the current state of play. Health Policy. 1996; 37: Golicki D, Jakubczyk M, Niewada M, et al. Valuation of EQ 5D Health States in Poland: First TTO Based Social Value Set in Central and Eastern Europe. Value Health. 2010; 13: Agency for Health Technology Assessment. Guidelines for conducting Health Technology Assessment (HTA). Version POLSKIE ARCHIWUM MEDYCYNY WEWNĘTRZNEJ 2010; 120 (7-8)

6 ARTYKUŁ ORYGINALNY Samoocena stanu zdrowia w Polsce wyniki polskiego badania ewaluacyjnego kwestionariusza EQ 5D Dominik Golicki 1, Maciej Niewada 2, Michał Jakubczyk 1,3, Witold Wrona 1, Tomasz Hermanowski 1 1 Zakład Farmakoekonomiki, Warszawski Uniwersytet Medyczny, Warszawa 2 Katedra i Zakład Farmako logii Doświadczalnej i Klinicznej, Warszawski Uniwersytet Medyczny, Warszawa 3 Instytut Ekonometrii, Szkoła Główna Handlowa w Warszawie, Warszawa Słowa kluczowe EQ 5D, EuroQol, jakość życia zależna od zdrowia, normy populacyjne, populacja ogólna Adres do korespondencji: dr med. Dominik Golicki, Zakład Farmakoekonomiki, Warszawski Uniwersytet Medyczny, ul. Pawińskiego 3a, Warszawa, tel.: , fax: , e mail: dominik.golicki@wum.edu.pl Praca wpłynęła: Przyjęta do druku: Nie zgłoszono sprzeczności inter esów. Pol Arch Med Wewn. 2010; 120 (7-8): Copyright by Medycyna Praktyczna, Kraków 2010 Streszczenie Wprowadzenie Dotąd nie opublikowano polskich norm populacyjnych dla żadnego z kwestionariuszy służących do oceny ogólnej jakości życia zależnej od zdrowia. Cele Celem badania była ocena stanu zdrowia reprezentatywnej próby ogólnej populacji polskiej za pomocą kwestionariusza oceny jakości życia EQ 5D. Materiał i metody W trakcie polskiego badania ewaluacyjnego kwestionariusza EQ 5D, przeprowadzono wywiady z pełnoletnimi gośćmi pacjentów szpitalnych w 8 ośrodkach medycznych w Warszawie, Skierniewicach i Puławach. Wyboru próby dokonano metodą warstwowego doboru losowego. Respondenci byli proszeni o wypełnienie kwestionariusza EQ 5D oraz udzielenie informacji dotyczących: wieku, płci, stanu cywilnego, wykształcenia, zatrudnienia, dochodu, warunków mieszkaniowych, wywiadu medycznego oraz uzależnienia od nikotyny. Wywiady przeprowadzano między lutym a majem Wyniki Otrzymana próba (n = 317) była reprezentatywna dla populacji polskiej pod względem wieku i płci. Umiarkowane problemy w zakresie co najmniej jednej domeny jakości życia zgłosiło 57% respondentów, skrajne problemy 4,7%. Ból lub dyskomfort odczuwało 40% ankietowanych, niepokój lub obniżenie nastroju 38%. Problemy z chodzeniem zgłosiło 16% ankietowanych, z wykonywaniem codziennych czynności (pracą zawodową, nauką) 13%, z dbaniem o siebie (myciem się, ubieraniem) 3%. Średnia ocena stanu zdrowia według wizualnej skali analogowej (visual analogue scale VAS) wyniosła 81,6 ±14,4 punktów. Ocena stanu zdrowia według VAS malała wraz z wiekiem: z 87 i 91 punktów w najmłodszej grupie wiekowej, do 67 i 72 punktów w najstarszej grupie wiekowej, odpowiednio u mężczyzn i kobiet. Wnioski Ból i niepokój są częstymi problemami Polaków, szczególnie młodych kobiet. Kwestionariusz EQ 5D jest cennym narzędziem do wykorzystania w badaniach wyników leczenia oraz różnic w stanie zdrowia populacji polskiej. ARTYKUŁ ORYGINALNY Samoocena stanu zdrowia w Polsce